FDA 510(k) Applications for Medical Device Product Code "DHN"
(Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K120889 AESKU DIAGNOSTICS AESKUSLIDES ANA HEP-2 10/15/2012
K153117 AESKU. SYSTEMS GMBH & CO. KG AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM 07/28/2016
K854314 AMERICAN BIO-REAGENTS, INC. FANA 60 12/16/1985
K822682 AMICO LAB, INC. ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K 12/03/1982
K822681 AMICO LAB, INC. ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) 12/13/1982
K812314 ANTIBODIES INC. CRITHIDNA ANTI-DNA TEST KIT 09/01/1981
K842183 APPLE DIAGNOSTIC PRODUCTS ADP ANA IFA TEST 06/22/1984
K834241 APPLE DIAGNOSTIC PRODUCTS ANA APPLELISA 04/04/1984
K801046 ARMKEL, LLC. ANATON 05/14/1980
K833119 ATLANTIC ANTIBODIES AUTOIMMUNE TEST 1/2/3 SYSTEM 11/21/1983
K802527 BARTELS & STOUT, INC. TEST KIT FOR DETECTION OF ANTINUCLEAR 01/05/1981
K860183 BEHRING DIAGNOSTICS, INC. AFT-HEP SYSTEM 02/26/1986
K841776 BEHRING DIAGNOSTICS, INC. ANA SENSITIVITY/SPECIFICITY CONTROL 06/22/1984
K024222 BIO-RAD LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 01/15/2003
K024221 BIO-RAD LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 01/15/2003
K024230 BIO-RAD LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 01/15/2003
K984397 BIO-RAD LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 12/18/1998
K984398 BIO-RAD LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 12/18/1998
K984399 BIO-RAD LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 12/18/1998
K024229 BIO-RAD LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 01/15/2003
K984400 BIO-RAD LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 12/18/1998
K024217 BIO-RAD LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 01/15/2003
K024227 BIO-RAD LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 01/15/2003
K024231 BIO-RAD LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 01/13/2003
K024225 BIO-RAD LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 01/15/2003
K024224 BIO-RAD LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 01/15/2003
K024220 BIO-RAD LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 01/17/2003
K870458 BIOHYTECH INTERNATIONAL, INC. HISTONES EIA DIAGNOSTIC KIT 03/17/1987
K872845 BION ENT., LTD. BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM 08/17/1987
K802299 BIOWARE PRODUCTS K/K (ASMA/ANA) UNIVERSAL BIOPAK 01/29/1981
K830214 CALBIOCHEM-BEHRING CORP. AFT SYSTEM III 03/09/1983
K790280 CALBIOCHEM-BEHRING CORP. AUTOANTIBODY REAGENTS, AFT SYSTEM II 04/23/1979
K862821 CAPPEL DIAGNOSTICS, INC. CAPPEL DIAGNOSTICS ANA KIT 08/15/1986
K820945 CENTERS FOR DISEASE CONTROL AND PREVENTION SERA FOR ANTINUCLEAR ANTIBODIES 10/26/1982
K822397 CLINICAL SCIENCES, INC. ANA HEP-2 FLUORO-KIT 09/21/1982
K770057 CLINICAL SCIENCES, INC. NDNA IMMUNOPATH FLUORO-KIT 04/05/1977
K042680 CORGENIX, INC. RHIGENE HEP-ANA TEST SYSTEM 11/19/2004
K871801 CYTOTECH, INC. CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT 06/09/1987
K874873 DIAGNOSTIC PRODUCTS CORP. COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 02/10/1988
K863717 DIAMEDIX CORP. ANTI-DNA MICROASSAY 10/24/1986
K872560 DIAMEDIX CORP. ANTI-DNP MICROASSAY 07/21/1987
K843347 E.I. DUPONT DE NEMOURS & CO., INC. RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON 10/05/1984
K771376 ELECTRO-NUCLEONICS LABORATORIES, INC. IFA ANTI-NDNA 10/18/1977
K841127 ELECTRO-NUCLEONICS LABORATORIES, INC. VIRGO REAGENTS INDIRECT FLUORSCENT 04/25/1984
K141827 EUROIMMUN U.S., Inc. EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE 04/17/2015
K131791 EUROIMMUN US IFA 40: HEP-20-10 02/26/2014
K070763 EUROIMMUN US LLC EUROIMMUN ANA IFA: HEP-20-10 05/22/2007
K771064 GULL LABORATORIES, INC. ANA TEST 06/24/1977
K962276 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA DSDNA KIT (EIA METHOD) 12/05/1996
K902139 HEMAGEN DIAGNOSTICS, INC. HEMAGEN ENA [JO-I] KIT 05/18/1990
K013213 HYPERION, INC. HYPERION VISIQUANT ANA TEST KIT 06/04/2002
K022800 HYPERION, INC. VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM 11/25/2002
K772219 IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS FIAX TEST FOR ANTI-RUBELLA ANTIBODY 01/20/1978
K782041 IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS FIAX TEST KIT 01/03/1979
K884400 IMMCO DIAGNOSTICS, INC. ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) 11/04/1988
K172745 IMMCO Diagnostics, Inc. ImmuGlo HEp-2 Elite IFA 06/05/2018
K822607 IMMULOK, INC. ANTINUCLEAR ANTOBODY CELL SUBSTRATE 09/17/1982
K823055 IMMULOK, INC. FLOUROSET IMMUNOFLUORESCENT ANTIBODY 11/05/1982
K803276 IMMUNO CONCEPTS, INC. ANA-IFA TEST SYSTEM 01/26/1981
K843225 IMMUNO CONCEPTS, INC. COLORZYME NDNA TEST SYSTEM 11/01/1984
K810301 IMMUNO CONCEPTS, INC. CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST 02/25/1981
K950979 IMMUNO CONCEPTS, INC. HEP-2000 COLORZYME ANA-RO TEST SYSTEM 06/01/1995
K983924 IMMUNO CONCEPTS, INC. HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO 12/18/1998
K944096 IMMUNO CONCEPTS, INC. HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM 11/21/1994
K972145 IMMUNO CONCEPTS, INC. HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM 02/24/1998
K160265 Immuno Concepts, NA, Ltd. Image Navigator by Immuno Concepts 06/17/2016
K811022 IMMUNO-DIAGNOSTIC PRODUCTS, INC. ANA TEST KIT 04/23/1981
K810985 IMMUNO-PRODUCTS INDUSTRIES ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT 05/01/1981
K831054 IMMUNO-PRODUCTS INDUSTRIES ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB 04/27/1983
K150155 INOVA DIAGNOSTICS, INC. NOVA Lite DAPI ANA Kit 04/08/2015
K901596 INOVA DIAGNOSTICS, INC. NOVA LITE(TM) ANA KSL 05/02/1990
K901595 INOVA DIAGNOSTICS, INC. NOVA LITE(TM) ANA MK 04/26/1990
K880742 INOVA DIAGNOSTICS, INC. NOVA LITE(TM) DSDNA 03/25/1988
K832383 INTL. DIAGNOSTIC TECHNOLOGY IDT ANA STIQ ASSAY 08/31/1983
K760206 INTL. DIAGNOSTIC TECHNOLOGY TEST, DETECTION, ANTINUCLEAR ANTIBODIES 08/03/1976
K780899 KALLESTAD LABORATORIES, INC. FLUORESCENT ANTI-NATIVE DNA TEST 09/07/1978
K813592 KALLESTAD LABORATORIES, INC. QUANTAFLUOR FLUORESCENT TEST REAGENTS 01/18/1982
K791928 KEITH E. ABBOTT ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT 11/13/1979
K894659 LIPOGEN, INC. ANA ANTISERA CONTROL KIT 09/21/1989
K791995 MEDA STAT DIAGNOSTICS, INC. ANTI NUCLEAR ANTIBODY TEST 10/30/1979
K831408 MEDASTAT SCIENTIFIC CORP. DNA FLOR 07/28/1983
K782048 MEDICA CORP. TEST KIT, IIF-ANA 01/17/1979
K820265 MELOY LABORATORIES, INC. ANA TEST (MOUSE LIVER SUBSTRATE) 02/12/1982
K790252 MELOY LABORATORIES, INC. ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI 03/15/1979
K791493 MELOY LABORATORIES, INC. ANTI-NUCLEAR ANTIBODY TEST 09/24/1979
K844678 MELOY LABORATORIES, INC. MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL 01/04/1985
K852033 MELOY LABORATORIES, INC. SS-A(RO) & SS-B(LA) ANTIBODY ASSAY 06/21/1985
K792184 MILES LABORATORIES, INC. LAB-TEK ANA TEST KIT 11/30/1979
K851369 MODERN DIAGNOSTICS, INC. ANTINUCLEAR ANTIBODY TEST KIT 05/15/1985
K012163 POLYMEDCO, INC. POLYTITER SYSTEM 08/20/2001
K970198 SCIMEDX CORP. IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES 02/20/1997
K811714 SCRIPPS-MILES, INC. HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT 07/10/1981
K810081 SCRIPPS-MILES, INC. SCRIPPSERA ANA REFERENCE CONTROL SERA 02/09/1981
K912292 SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-JO-1 KIT 07/30/1991
K990915 STELLAR BIO SYSTEMS, INC. INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY 04/21/1999
K841984 TECH AMERICA DIAGNOSTICS AUTOFLOUR III SYSTEM 11/01/1984
K842991 TECH AMERICA DIAGNOSTICS AUTOFLUOR V SYSTEM 03/14/1985
K001556 THE BINDING SITE, LTD. HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY 08/21/2000
K926114 TISSUE CULTURE BIOTEC, INC. HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM 05/20/1993
K964165 TRIANGLE BIOMEDICAL SCIENCES, INC. MICRO21 WITH NDNA 01/03/1997
K871395 VAL TECH DIAGNOSTICS, INC. DUAL SUBSTRATE ANA 04/20/1987
K870732 VAL TECH DIAGNOSTICS, INC. RAT LIVER NUCLEI TEST SYSTEM 03/10/1987
K871144 VITROTEC LABORATORIES, INC. TANGENT SYSTEM(TM) ANA PROFILE TEST KIT 04/29/1987
K760681 WAMPOLE LABORATORIES INDIRECT FLUORESCENT (IFA-ANA) 10/21/1976
K760209 ZEUS SCIENTIFIC, INC. ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP 07/26/1976
K897025 ZEUS SCIENTIFIC, INC. ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM 01/02/1990
K780161 ZEUS SCIENTIFIC, INC. IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER 02/07/1978
K780178 ZEUS SCIENTIFIC, INC. TEST SYS. FOR NDNA ANTIBODY DETERM. 02/13/1978
K760153 ZEUS SCIENTIFIC, INC. TEST, (IVDP) ANTINUCLEAR ANTIBODY 07/20/1976


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